Methods and apparatus for transmitting vibrations

ABSTRACT

Methods and apparatus for transmitting vibrations via an electronic and/or transducer assembly through a tooth or teeth are disclosed herein. The assembly may be attached, adhered, or otherwise embedded into or upon a removable oral appliance to form a hearing aid assembly. Such an oral appliance may be a custom-made device. The electronic and transducer assembly may receive incoming sounds either directly or through a receiver to process and amplify the signals and transmit the processed sounds via a vibrating transducer element coupled to a tooth or other bone structure, such as the maxillary, mandibular, or palatine bone structure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/754,823 filed May 29, 2007 which claims the benefit of priority toU.S. Provisional Patent Application Ser. Nos. 60/809,244 filed May 30,2006 and 60/820,223 filed Jul. 24, 2006, each of which is incorporatedherein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for transmittingvibrations through teeth or bone structures in and/or around a mouth.More particularly, the present invention relates to methods andapparatus for sound conduction through teeth or bone structures inand/or around the mouth by transmitting vibrations correlating toauditory signals received by a user.

BACKGROUND OF THE INVENTION

Hearing loss affects over 31 million people in the United States (about13% of the population). As a chronic condition, the incidence of hearingimpairment rivals that of heart disease and, like heart disease, theincidence of hearing impairment increases sharply with age.

While the vast majority of those with hearing loss can be helped by awell-fitted, high quality hearing device, only 22% of the total hearingimpaired population own hearing devices. Current products anddistribution methods are not able to satisfy or reach over 20 millionpersons with hearing impairment in the U.S. alone.

Hearing loss adversely affects a person's quality of life andpsychological well-being. Individuals with hearing impairment oftenwithdraw from social interactions to avoid frustrations resulting frominability to understand conversations. Recent studies have shown thathearing impairment causes increased stress levels, reducedself-confidence, reduced sociability and reduced effectiveness in theworkplace.

The human ear generally comprises three regions: the outer ear, themiddle ear, and the inner ear. The outer ear generally comprises theexternal auricle and the ear canal, which is a tubular pathway throughwhich sound reaches the middle ear. The outer ear is separated from themiddle ear by the tympanic membrane (eardrum). The middle ear generallycomprises three small bones, known as the ossicles, which form amechanical conductor from the tympanic membrane to the inner ear.Finally, the inner ear includes the cochlea, which is a fluid-filledstructure that contains a large number of delicate sensory hair cellsthat are connected to the auditory nerve.

Hearing loss can also be classified in terms of being conductive,sensorineural, or a combination of both. Conductive hearing impairmenttypically results from diseases or disorders that limit the transmissionof sound through the middle ear. Most conductive impairments can betreated medically or surgically. Purely conductive hearing lossrepresents a relatively small portion of the total hearing impairedpopulation (estimated at less than 5% of the total hearing impairedpopulation).

Sensorineural hearing losses occur mostly in the inner ear and accountfor the vast majority of hearing impairment (estimated at 90-95% of thetotal hearing impaired population). Sensorineural hearing impairment(sometimes called “nerve loss”) is largely caused by damage to thesensory hair cells inside the cochlea. Sensorineural hearing impairmentoccurs naturally as a result of aging or prolonged exposure to loudmusic and noise. This type of hearing loss cannot be reversed nor can itbe medically or surgically treated; however, the use of properly fittedhearing devices can improve the individual's quality of life.

Conventional hearing devices are the most common devices used to treatmild to severe sensorineural hearing impairment. These are acousticdevices that amplify sound to the tympanic membrane. These devices areindividually customizable to the patient's physical and acousticalcharacteristics over four to six separate visits to an audiologist orhearing instrument specialist. Such devices generally comprise amicrophone, amplifier, battery, and speaker. Recently, hearing devicemanufacturers have increased the sophistication of sound processing,often using digital technology, to provide features such asprogrammability and multi-band compression. Although these devices havebeen miniaturized and are less obtrusive, they are still visible andhave major acoustic limitation.

Industry research has shown that the primary obstacles for notpurchasing a hearing device generally include: a) the stigma associatedwith wearing a hearing device; b) dissenting attitudes on the part ofthe medical profession, particularly ENT physicians; c) product valueissues related to perceived performance problems; d) general lack ofinformation and education at the consumer and physician level; and e)negative word-of-mouth from dissatisfied users.

Other devices such as cochlear implants have been developed for peoplewho have severe to profound hearing loss and are essentially deaf(approximately 2% of the total hearing impaired population). Theelectrode of a cochlear implant is inserted into the inner ear in aninvasive and non-reversible surgery. The electrode electricallystimulates the auditory nerve through an electrode array that providesaudible cues to the user, which are not usually interpreted by the brainas normal sound. Users generally require intensive and extendedcounseling and training following surgery to achieve the expectedbenefit.

Other devices such as electronic middle ear implants generally aresurgically placed within the middle ear of the hearing impaired. Theyare surgically implanted devices with an externally worn component.

The manufacture, fitting and dispensing of hearing devices remain anarcane and inefficient process. Most hearing devices are custommanufactured, fabricated by the manufacturer to fit the ear of eachprospective purchaser. An impression of the ear canal is taken by thedispenser (either an audiologist or licensed hearing instrumentspecialist) and mailed to the manufacturer for interpretation andfabrication of the custom molded rigid plastic casing. Hand-wiredelectronics and transducers (microphone and speaker) are then placedinside the casing, and the final product is shipped back to thedispensing professional after some period of time, typically one to twoweeks.

The time cycle for dispensing a hearing device, from the firstdiagnostic session to the final fine-tuning session, typically spans aperiod over several weeks, such as six to eight weeks, and involvesmultiple with the dispenser.

Accordingly, there exists a need for methods and devices which areefficacious and safe in facilitating the treatment of hearing loss inpatients.

SUMMARY OF THE INVENTION

An electronic and transducer device may be attached, adhered, orotherwise embedded into or upon a removable dental or oral appliance toform a hearing aid assembly.

Such a removable oral appliance may be a custom-made device fabricatedfrom a thermal forming process utilizing a replicate model of a dentalstructure obtained by conventional dental impression methods. Theelectronic and transducer assembly may receive incoming sounds eitherdirectly or through a receiver to process and amplify the signals andtransmit the processed sounds via a vibrating transducer element coupledto a tooth or other bone structure, such as the maxillary, mandibular,or palatine bone structure.

The assembly for transmitting vibrations via at least one tooth maygenerally comprise a housing having a shape which is conformable to atleast a portion of the at least one tooth, and an actuatable transducerdisposed within or upon the housing and in vibratory communication witha surface of the at least one tooth. Moreover, the transducer itself maybe a separate assembly from the electronics and may be positioned alonganother surface of the tooth, such as the occlusal surface, or evenattached to an implanted post or screw embedded into the underlyingbone. Additionally, the transducer may also be placed directly onto thegingival tissue surface adjacent to the tooth for vibratory transmissionthrough the tissue and into the underlying bone.

One example of a method for transmitting these vibrations via at leastone tooth may generally comprising positioning a housing of theremovable oral appliance onto at least one tooth, whereby the housinghas a shape which is conformable to at least a portion of the tooth, andmaintaining contact between a surface of the tooth with an actuatabletransducer such that the surface and transducer remain in vibratorycommunication.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the dentition of a patient's teeth and one variationof a hearing aid device which is removably placed upon or against thepatient's tooth or teeth as a removable oral appliance.

FIG. 2A illustrates a perspective view of the lower teeth showing oneexemplary location for placement of the removable oral appliance hearingaid device.

FIG. 2B illustrates another variation of the removable oral appliance inthe form of an appliance which is placed over an entire row of teeth inthe manner of a mouthguard.

FIG. 2C illustrates another variation of the removable oral appliancewhich is supported by an arch.

FIG. 2D illustrates another variation of an oral appliance configured asa mouthguard.

FIG. 3 illustrates a detail perspective view of the oral appliancepositioned upon the patient's teeth utilizable in combination with atransmitting assembly external to the mouth and wearable by the patientin another variation of the device.

FIG. 4 shows an illustrative configuration of the individual componentsin a variation of the oral appliance device having an externaltransmitting assembly with a receiving and transducer assembly withinthe mouth.

FIG. 5 shows an illustrative configuration of another variation of thedevice in which the entire assembly is contained by the oral appliancewithin the user's mouth.

FIG. 6A shows a partial cross-sectional view of an oral appliance placedupon a tooth with an electronics/transducer assembly adhered to thetooth surface via an adhesive.

FIG. 6B shows a partial cross-sectional view of a removable backingadhered onto an adhesive surface.

FIG. 7 shows a partial cross-sectional view of another variation of anoral appliance placed upon a tooth with an electronics/transducerassembly pressed against the tooth surface via an osmotic pouch.

FIG. 8 shows a partial cross-sectional view of another variation of anoral appliance placed upon a tooth with an electronics/transducerassembly pressed against the tooth surface via one or more biasingelements.

FIG. 9 illustrates another variation of an oral appliance having anelectronics assembly and a transducer assembly separated from oneanother within the electronics and transducer housing of the oralappliance.

FIGS. 10 and 11 illustrate additional variations of oral appliances inwhich the electronics and transducer assembly are maintainable againstthe tooth surface via a ramped surface and a biasing element.

FIG. 12 shows yet another variation of an oral appliance having aninterfacing member positioned between the electronics and/or transducerassembly and the tooth surface.

FIG. 13 shows yet another variation of an oral appliance having anactuatable mechanism for urging the electronics and/or transducerassembly against the tooth surface.

FIG. 14 shows yet another variation of an oral appliance having a cammechanism for urging the electronics and/or transducer assembly againstthe tooth surface.

FIG. 15 shows yet another variation of an oral appliance having aseparate transducer mechanism positionable upon the occlusal surface ofthe tooth for transmitting vibrations.

FIG. 16 illustrates another variation of an oral appliance having amechanism for urging the electronics and/or transducer assembly againstthe tooth surface utilizing a bite-actuated mechanism.

FIG. 17 shows yet another variation of an oral appliance having acomposite dental anchor for coupling the transducer to the tooth.

FIGS. 18A and 18B show side and top views, respectively, of an oralappliance variation having one or more transducers which may bepositioned over the occlusal surface of the tooth.

FIGS. 19A and 19B illustrate yet another variation of an oral appliancemade from a shape memory material in its pre-formed relaxedconfiguration and its deformed configuration when placed over or uponthe patient's tooth, respectively, to create an interference fit.

FIG. 20 illustrates yet another variation of an oral appliance made froma pre-formed material in which the transducer may be positioned betweenthe biased side of the oral appliance and the tooth surface.

FIG. 21 illustrates a variation in which the oral appliance may beomitted and the electronics and/or transducer assembly may be attachedto a composite dental anchor attached directly to the tooth surface.

FIGS. 22A and 22B show partial cross-sectional side and perspectiveviews, respectively, of another variation of an oral appliance assemblyhaving its occlusal surface removed or omitted for patient comfort.

FIGS. 23A and 23B illustrate perspective and side views, respectively,of an oral appliance which may be coupled to a screw or post implanteddirectly into the underlying bone, such as the maxillary or mandibularbone.

FIG. 24 illustrates another variation in which the oral appliance may becoupled to a screw or post implanted directly into the palate of apatient.

FIGS. 25A and 25B illustrate perspective and side views, respectively,of an oral appliance which may have its transducer assembly or acoupling member attached to the gingival surface to conduct vibrationsthrough the gingival tissue and underlying bone.

FIG. 26 illustrates an example of how multiple oral appliance hearingaid assemblies or transducers may be placed on multiple teeth throughoutthe patient's mouth.

FIGS. 27A and 27B illustrate perspective and side views, respectively,of an oral appliance (similar to a variation shown above) which may havea microphone unit positioned adjacent to or upon the gingival surface tophysically separate the microphone from the transducer to attenuate oreliminate feedback.

FIG. 28 illustrates another variation of a removable oral appliancesupported by an arch and having a microphone unit integrated within thearch.

FIG. 29 shows yet another variation illustrating at least one microphoneand optionally additional microphone units positioned around the user'smouth and in wireless communication with the electronics and/ortransducer assembly.

DETAILED DESCRIPTION OF THE INVENTION

An electronic and transducer device may be attached, adhered, orotherwise embedded into or upon a removable oral appliance or other oraldevice to form a hearing aid assembly. Such an oral appliance may be acustom-made device fabricated from a thermal forming process utilizing areplicate model of a dental structure obtained by conventional dentalimpression methods. The electronic and transducer assembly may receiveincoming sounds either directly or through a receiver to process andamplify the signals and transmit the processed sounds via a vibratingtransducer element coupled to a tooth or other bone structure, such asthe maxillary, mandibular, or palatine bone structure.

As shown in FIG. 1, a patient's mouth and dentition 10 is illustratedshowing one possible location for removably attaching hearing aidassembly 14 upon or against at least one tooth, such as a molar 12. Thepatient's tongue TG and palate PL are also illustrated for reference. Anelectronics and/or transducer assembly 16 may be attached, adhered, orotherwise embedded into or upon the assembly 14, as described below infurther detail.

FIG. 2A shows a perspective view of the patient's lower dentitionillustrating the hearing aid assembly 14 comprising a removable oralappliance 18 and the electronics and/or transducer assembly 16positioned along a side surface of the assembly 14. In this variation,oral appliance 18 may be fitted upon two molars 12 within tooth engagingchannel 20 defined by oral appliance 18 for stability upon the patient'steeth, although in other variations, a single molar or tooth may beutilized. Alternatively, more than two molars may be utilized for theoral appliance 18 to be attached upon or over. Moreover, electronicsand/or transducer assembly 16 is shown positioned upon a side surface oforal appliance 18 such that the assembly 16 is aligned along a buccalsurface of the tooth 12; however, other surfaces such as the lingualsurface of the tooth 12 and other positions may also be utilized. Thefigures are illustrative of variations and are not intended to belimiting; accordingly, other configurations and shapes for oralappliance 18 are intended to be included herein.

FIG. 2B shows another variation of a removable oral appliance in theform of an appliance 15 which is placed over an entire row of teeth inthe manner of a mouthguard. In this variation, appliance 15 may beconfigured to cover an entire bottom row of teeth or alternatively anentire upper row of teeth. In additional variations, rather thancovering the entire rows of teeth, a majority of the row of teeth may beinstead be covered by appliance 15. Assembly 16 may be positioned alongone or more portions of the oral appliance 15.

FIG. 2C shows yet another variation of an oral appliance 17 having anarched configuration. In this appliance, one or more tooth retainingportions 21, 23, which in this variation may be placed along the upperrow of teeth, may be supported by an arch 19 which may lie adjacent oralong the palate of the user. As shown, electronics and/or transducerassembly 16 may be positioned along one or more portions of the toothretaining portions 21, 23. Moreover, although the variation shownillustrates an arch 19 which may cover only a portion of the palate ofthe user, other variations may be configured to have an arch whichcovers the entire palate of the user.

FIG. 2D illustrates yet another variation of an oral appliance in theform of a mouthguard or retainer 25 which may be inserted and removedeasily from the user's mouth. Such a mouthguard or retainer 25 may beused in sports where conventional mouthguards are worn; however,mouthguard or retainer 25 having assembly 16 integrated therein may beutilized by persons, hearing impaired or otherwise, who may simply holdthe mouthguard or retainer 25 via grooves or channels 26 between theirteeth for receiving instructions remotely and communicating over adistance.

Generally, the volume of electronics and/or transducer assembly 16 maybe minimized so as to be unobtrusive and as comfortable to the user whenplaced in the mouth. Although the size may be varied, a volume ofassembly 16 may be less than 800 cubic millimeters. This volume is, ofcourse, illustrative and not limiting as size and volume of assembly 16and may be varied accordingly between different users.

Moreover, removable oral appliance 18 may be fabricated from variouspolymeric or a combination of polymeric and metallic materials using anynumber of methods, such as computer-aided machining processes usingcomputer numerical control (CNC) systems or three-dimensional printingprocesses, e.g., stereolithography apparatus (SLA), selective lasersintering (SLS), and/or other similar processes utilizingthree-dimensional geometry of the patient's dentition, which may beobtained via any number of techniques. Such techniques may include useof scanned dentition using intra-oral scanners such as laser, whitelight, ultrasound, mechanical three-dimensional touch scanners, magneticresonance imaging (MRI), computed tomography (CT), other opticalmethods, etc.

In forming the removable oral appliance 18, the appliance 18 may beoptionally formed such that it is molded to fit over the dentition andat least a portion of the adjacent gingival tissue to inhibit the entryof food, fluids, and other debris into the oral appliance 18 and betweenthe transducer assembly and tooth surface. Moreover, the greater surfacearea of the oral appliance 18 may facilitate the placement andconfiguration of the assembly 16 onto the appliance 18.

Additionally, the removable oral appliance 18 may be optionallyfabricated to have a shrinkage factor such that when placed onto thedentition, oral appliance 18 may be configured to securely grab onto thetooth or teeth as the appliance 18 may have a resulting size slightlysmaller than the scanned tooth or teeth upon which the appliance 18 wasformed. The fitting may result in a secure interference fit between theappliance 18 and underlying dentition.

In one variation, with assembly 14 positioned upon the teeth, as shownin FIG. 3, an extra-buccal transmitter assembly 22 located outside thepatient's mouth may be utilized to receive auditory signals forprocessing and transmission via a wireless signal 24 to the electronicsand/or transducer assembly 16 positioned within the patient's mouth,which may then process and transmit the processed auditory signals viavibratory conductance to the underlying tooth and consequently to thepatient's inner ear.

The transmitter assembly 22, as described in further detail below, maycontain a microphone assembly as well as a transmitter assembly and maybe configured in any number of shapes and forms worn by the user, suchas a watch, necklace, lapel, phone, belt-mounted device, etc.

FIG. 4 illustrates a schematic representation of one variation ofhearing aid assembly 14 utilizing an extra-buccal transmitter assembly22, which may generally comprise microphone 30 for receiving sounds andwhich is electrically connected to processor 32 for processing theauditory signals. Processor 32 may be connected electrically totransmitter 34 for transmitting the processed signals to the electronicsand/or transducer assembly 16 disposed upon or adjacent to the user'steeth. The microphone 30 and processor 32 may be configured to detectand process auditory signals in any practicable range, but may beconfigured in one variation to detect auditory signals ranging from,e.g., 250 Hertz to 20,000 Hertz.

With respect to microphone 30, a variety of various microphone systemsmay be utilized. For instance, microphone 30 may be a digital, analog,and/or directional type microphone. Such various types of microphonesmay be interchangeably configured to be utilized with the assembly, ifso desired.

Power supply 36 may be connected to each of the components intransmitter assembly 22 to provide power thereto. The transmittersignals 24 may be in any wireless form utilizing, e.g., radio frequency,ultrasound, microwave, Blue Tooth® (BLUETOOTH SIG, INC., Bellevue,Wash.), etc. for transmission to assembly 16. Assembly 22 may alsooptionally include one or more input controls 28 that a user maymanipulate to adjust various acoustic parameters of the electronicsand/or transducer assembly 16, such as acoustic focusing, volumecontrol, filtration, muting, frequency optimization, sound adjustments,and tone adjustments, etc.

The signals transmitted 24 by transmitter 34 may be received byelectronics and/or transducer assembly 16 via receiver 38, which may beconnected to an internal processor for additional processing of thereceived signals. The received signals may be communicated to transducer40, which may vibrate correspondingly against a surface of the tooth toconduct the vibratory signals through the tooth and bone andsubsequently to the middle ear to facilitate hearing of the user.Transducer 40 may be configured as any number of different vibratorymechanisms. For instance, in one variation, transducer 40 may be anelectromagnetically actuated transducer. In other variations, transducer40 may be in the form of a piezoelectric crystal having a range ofvibratory frequencies, e.g., between 250 to 4000 Hz.

Power supply 42 may also be included with assembly 16 to provide powerto the receiver, transducer, and/or processor, if also included.Although power supply 42 may be a simple battery, replaceable orpermanent, other variations may include a power supply 42 which ischarged by inductance via an external charger. Additionally, powersupply 42 may alternatively be charged via direct coupling to analternating current (AC) or direct current (DC) source. Other variationsmay include a power supply 42 which is charged via a mechanicalmechanism, such as an internal pendulum or slidable electricalinductance charger as known in the art, which is actuated via, e.g.,motions of the jaw and/or movement for translating the mechanical motioninto stored electrical energy for charging power supply 42.

In another variation of assembly 16, rather than utilizing anextra-buccal transmitter, hearing aid assembly 50 may be configured asan independent assembly contained entirely within the user's mouth, asshown in FIG. 5. Accordingly, assembly 50 may include an internalmicrophone 52 in communication with an on-board processor 54. Internalmicrophone 52 may comprise any number of different types of microphones,as described above. Processor 54 may be used to process any receivedauditory signals for filtering and/or amplifying the signals andtransmitting them to transducer 56, which is in vibratory contactagainst the tooth surface. Power supply 58, as described above, may alsobe included within assembly 50 for providing power to each of thecomponents of assembly 50 as necessary.

In order to transmit the vibrations corresponding to the receivedauditory signals efficiently and with minimal loss to the tooth orteeth, secure mechanical contact between the transducer and the tooth isideally maintained to ensure efficient vibratory communication.Accordingly, any number of mechanisms may be utilized to maintain thisvibratory communication.

In one variation as shown in FIG. 6A, a partial cross-sectional view ofa removable oral appliance 60 is shown placed over or upon a tooth TH.Electronics and/or transducer housing 62 may be seen defined along oralappliance 60 such that housing 62 is aligned or positioned adjacent to aside surface, buccal and/or lingual surface, of the tooth TH. Housing 62may provide protection to the electronics and/or transducer assemblyfrom the environment of the mouth.

An electronics and/or transducer assembly 64 may be simply placed,embedded, or encapsulated within housing 62 for contacting the toothsurface. In this variation, assembly 64 may be adhered against the toothsurface via an adhesive surface or film 66 such that contact ismaintained between the two. As shown in FIG. 6B, a removable backing 68may be adhered onto adhesive surface 66 and removed prior to placementupon the tooth surface. In this manner, assembly 64 may be replaced uponthe tooth as necessary with additional electronics and/or transducerassemblies.

Aside from an adhesive film 66, another alternative may utilize anexpandable or swellable member to ensure a secure mechanical contact ofthe transducer against the tooth. As shown in FIG. 7, an osmotic patchor expandable hydrogel 74 may be placed between housing 62 andelectronics and/or transducer assembly 72. After placement of oralappliance 60, hydrogel 74 may absorb some fluids, either from anysurrounding fluid or from a fluid introduced into hydrogel 74, such thathydrogel 74 expands in size to force assembly 72 into contact againstthe tooth surface. Assembly 72 may be configured to define a contactsurface 70 having a relatively smaller contact area to facilitateuniform contact of the surface 70 against the tooth. Such a contactsurface 70 may be included in any of the variations described herein.Additionally, a thin encapsulating layer or surface 76 may be placedover housing 62 between contact surface 70 and the underlying tooth toprevent any debris or additional fluids from entering housing 62.

Another variation is shown in FIG. 8, which shows electronics and/ortransducer assembly 80 contained within housing 62. In this variation,one or more biasing elements 82, e.g., springs, pre-formed shape memoryelements, etc., may be placed between assembly 80 and housing 62 toprovide a pressing force on assembly 80 to urge the device against theunderlying tooth surface, thereby ensuring mechanical contact.

In yet another variation, the electronics may be contained as a separateassembly 90 which is encapsulated within housing 62 and the transducer92 may be maintained separately from assembly 90 but also within housing62. As shown in FIG. 9, transducer 92 may be urged against the toothsurface via a spring or other biasing element 94 and actuated via any ofthe mechanisms described above.

In other variations as shown in FIG. 10, electronics and/or transducerassembly 100 may be configured to have a ramped surface 102 inapposition to the tooth surface. The surface 102 may be angled away fromthe occlusal surface of the tooth. The assembly 100 may be urged via abiasing element or spring 106 which forces the ramped surface 102 topivot about a location 104 into contact against the tooth to ensurecontact for the transducer against the tooth surface.

FIG. 11 illustrates another similar variation in electronics and/ortransducer assembly 110 also having a ramped surface 112 in appositionto the tooth surface. In this variation, the ramped surface 112 may beangled towards the occlusal surface of the tooth. Likewise, assembly 110may be urged via a biasing element or spring 116 which urges theassembly 110 to pivot about its lower end such that the assembly 110contacts the tooth surface at a region 114.

In yet another variation shown in FIG. 12, electronics and/or transducerassembly 120 may be positioned within housing 62 with an interface layer122 positioned between the assembly 120 and the tooth surface. Interfacelayer 122 may be configured to conform against the tooth surface andagainst assembly 120 such that vibrations may be transmitted throughlayer 122 and to the tooth in a uniform manner. Accordingly, interfacelayer 122 may be made from a material which attenuates vibrationsminimally. Interface layer 122 may be made in a variety of forms, suchas a simple insert, an O-ring configuration, etc. or even in a gel orpaste form, such as denture or oral paste, etc. Additionally, layer 122may be fabricated from various materials, e.g., hard plastics orpolymeric materials, metals, etc.

FIG. 13 illustrates yet another variation in which electronics and/ortransducer assembly 130 may be urged against the tooth surface via amechanical mechanism. As shown, assembly 130 may be attached to astructural member 132, e.g., a threaded member or a simple shaft, whichis connected through housing 62 to an engagement member 134 locatedoutside housing 62. The user may rotate engagement member 134 (asindicated by rotational arrow 136) or simply push upon member 134 (asindicated by linear arrow 138) to urge assembly 130 into contact againstthe tooth. Moreover, actuation of engagement member 134 may beaccomplished manually within the mouth or through the user's cheek oreven through manipulation via the user's tongue against engagementmember 134.

Another variation for a mechanical mechanism is illustrated in FIG. 14.In this variation, electronics and/or transducer assembly 140 may definea portion as an engaging surface 142 for contacting against a cam orlever mechanism 144. Cam or lever mechanism 144 may be configured topivot 146 such that actuation of a lever 148 extending through housing62 may urge cam or lever mechanism 144 to push against engaging surface142 such that assembly 140 is pressed against the underlying toothsurface.

In yet another variation, the electronics 150 and the transducer 152 maybe separated from one another such that electronics 150 remain disposedwithin housing 62 but transducer 152, connected via wire 154, is locatedbeneath dental oral appliance 60 along an occlusal surface of the tooth,as shown in FIG. 15. In such a configuration, vibrations are transmittedvia the transducer 152 through the occlusal surface of the tooth.Additionally, the user may bite down upon the oral appliance 60 andtransducer 152 to mechanically compress the transducer 152 against theocclusal surface to further enhance the mechanical contact between thetransducer 152 and underlying tooth to further facilitate transmissiontherethrough.

In the variation of FIG. 16, another example for a bite-enhancedcoupling mechanism is illustrated where electronics and/or transducerassembly 160 defines an angled interface surface 162 in apposition to acorrespondingly angled engaging member 164. A proximal end of engagingmember 164 may extend through housing 62 and terminate in a pushermember 166 positioned over an occlusal surface of the tooth TH. Onceoral appliance 60 is initially placed over tooth TH, the user may bitedown or otherwise press down upon the top portion of oral appliance 60,thereby pressing down upon pusher member 166 which in turn pushes downupon engaging member 164, as indicated by the arrow. As engaging member164 is urged downwardly towards the gums, its angled surface may pushupon the corresponding and oppositely angled surface 162 to urgeassembly 160 against the tooth surface and into a secure mechanicalcontact.

In yet another variation, an electronics and/or transducer assembly 170may define a channel or groove 172 along a surface for engaging acorresponding dental anchor 174, as shown in FIG. 17. Dental anchor 174may comprise a light-curable acrylate-based composite material adhereddirectly to the tooth surface. Moreover dental anchor 174 may beconfigured in a shape which corresponds to a shape of channel or groove172 such that the two may be interfitted in a mating engagement. In thismanner, the transducer in assembly 170 may vibrate directly againstdental anchor 174 which may then transmit these signals directly intothe tooth TH.

FIGS. 18A and 18B show partial cross-sectional side and top views,respectively, of another variation in which oral appliance 180 maydefine a number of channels or grooves 184 along a top portion of oralappliance 180. Within these channels or grooves 184, one or moretransducers 182, 186, 188, 190 may be disposed such that they are incontact with the occlusal surface of the tooth and each of thesetransducers may be tuned to transmit frequencies uniformly.Alternatively, each of these transducers may be tuned to transmit onlyat specified frequency ranges. Accordingly, each transducer can beprogrammed or preset for a different frequency response such that eachtransducer may be optimized for a different frequency response and/ortransmission to deliver a relatively high-fidelity sound to the user.

In yet another variation, FIGS. 19A and 19B illustrate an oral appliance200 which may be pre-formed from a shape memory polymer or alloy or asuperelastic material such as a Nickel-Titanium alloy, e.g., Nitinol.FIG. 19A shows oral appliance 200 in a first configuration where members202, 204 are in an unbiased memory configuration. When placed upon oragainst the tooth TH, members 202, 204 may be deflected into a secondconfiguration where members 202′, 204′ are deformed to engage tooth THin a secure interference fit, as shown in FIG. 19B. The biased member204′ may be utilized to press the electronics and/or transducer assemblycontained therein against the tooth surface as well as to maintainsecurement of the oral appliance 200 upon the tooth TH.

Similarly, as shown in FIG. 20, removable oral appliance 210 may havebiased members to secure engage the tooth TH, as above. In thisvariation, the ends of the members 212, 214 may be configured intocurved portions under which a transducer element 218 coupled toelectronics assembly 216 may be wedged or otherwise secured to ensuremechanical contact against the tooth surface.

FIG. 21 shows yet another variation in which the oral appliance isomitted entirely. Here, a composite dental anchor or bracket 226, asdescribed above, may be adhered directly onto the tooth surface.Alternatively, bracket 226 may be comprised of a biocompatible material,e.g., stainless steel, Nickel-Titanium, Nickel, ceramics, composites,etc., formed into a bracket and anchored onto the tooth surface. Thebracket 226 may be configured to have a shape 228 over which anelectronics and/or transducer assembly 220 may be slid over or upon viaa channel 222 having a corresponding receiving configuration 224 forengagement with bracket 226. In this manner, assembly 220 may bedirectly engaged against bracket 226, through which a transducer maydirectly vibrate into the underlying tooth TH. Additionally, in theevent that assembly 220 is removed from the tooth TH, assembly 220 maybe simply slid or rotated off bracket 226 and a replacement assembly maybe put in its place upon bracket 226.

FIGS. 22A and 22B show partial cross-sectional side and perspectiveviews, respectively, of yet another variation of an oral appliance 230.In this variation, the oral appliance 230 may be configured to omit anocclusal surface portion of the oral appliance 230 and instead engagesthe side surfaces of the tooth TH, such as the lingual and buccalsurfaces only. The electronics and/or transducer assembly 234 may becontained, as above, within a housing 232 for contact against the toothsurface. Additionally, as shown in FIG. 22B, one or more optionalcross-members 236 may connect the side portions of the oral appliance230 to provide some structural stability when placed upon the tooth.This variation may define an occlusal surface opening 238 such that whenplaced upon the tooth, the user may freely bite down directly upon thenatural occlusal surface of the tooth unobstructed by the oral appliancedevice, thereby providing for enhanced comfort to the user.

In yet other variations, vibrations may be transmitted directly into theunderlying bone or tissue structures rather than transmitting directlythrough the tooth or teeth of the user. As shown in FIG. 23A, an oralappliance 240 is illustrated positioned upon the user's tooth, in thisexample upon a molar located along the upper row of teeth. Theelectronics and/or transducer assembly 242 is shown as being locatedalong the buccal surface of the tooth. Rather than utilizing atransducer in contact with the tooth surface, a conduction transmissionmember 244, such as a rigid or solid metallic member, may be coupled tothe transducer in assembly 242 and extend from oral appliance 240 to apost or screw 246 which is implanted directly into the underlying bone248, such as the maxillary bone, as shown in the partial cross-sectionalview of FIG. 23B. As the distal end of transmission member 244 iscoupled directly to post or screw 246, the vibrations generated by thetransducer may be transmitted through transmission member 244 anddirectly into post or screw 246, which in turn transmits the vibrationsdirectly into and through the bone 248 for transmission to the user'sinner ear.

FIG. 24 illustrates a partial cross-sectional view of an oral appliance250 placed upon the user's tooth TH with the electronics and/ortransducer assembly 252 located along the lingual surface of the tooth.Similarly, the vibrations may be transmitted through the conductiontransmission member 244 and directly into post or screw 246, which inthis example is implanted into the palatine bone PL. Other variationsmay utilize this arrangement located along the lower row of teeth fortransmission to a post or screw 246 drilled into the mandibular bone.

In yet another variation, rather utilizing a post or screw drilled intothe underlying bone itself, a transducer may be attached, coupled, orotherwise adhered directly to the gingival tissue surface adjacent tothe teeth. As shown in FIGS. 25A and 25B, an oral appliance 260 may havean electronics assembly 262 positioned along its side with an electricalwire 264 extending therefrom to a transducer assembly 266 attached tothe gingival tissue surface 268 next to the tooth TH. Transducerassembly 266 may be attached to the tissue surface 268 via an adhesive,structural support arm extending from oral appliance 260, a dental screwor post, or any other structural mechanism. In use, the transducer mayvibrate and transmit directly into the underlying gingival tissue, whichmay conduct the signals to the underlying bone.

For any of the variations described above, they may be utilized as asingle device or in combination with any other variation herein, aspracticable, to achieve the desired hearing level in the user. Moreover,more than one oral appliance device and electronics and/or transducerassemblies may be utilized at any one time. For example, FIG. 26illustrates one example where multiple transducer assemblies 270, 272,274, 276 may be placed on multiple teeth. Although shown on the lowerrow of teeth, multiple assemblies may alternatively be positioned andlocated along the upper row of teeth or both rows as well. Moreover,each of the assemblies may be configured to transmit vibrations within auniform frequency range. Alternatively in other variations, differentassemblies may be configured to vibrate within non-overlapping frequencyranges between each assembly. As mentioned above, each transducer 270,272, 274, 276 can be programmed or preset for a different frequencyresponse such that each transducer may be optimized for a differentfrequency response and/or transmission to deliver a relativelyhigh-fidelity sound to the user.

Moreover, each of the different transducers 270, 272, 274, 276 can alsobe programmed to vibrate in a manner which indicates the directionalityof sound received by the microphone worn by the user. For example,different transducers positioned at different locations within theuser's mouth can vibrate in a specified manner by providing sound orvibrational queues to inform the user which direction a sound wasdetected relative to an orientation of the user. For instance, a firsttransducer located, e.g., on a user's left tooth, can be programmed tovibrate for sound detected originating from the user's left side.Similarly, a second transducer located, e.g., on a user's right tooth,can be programmed to vibrate for sound detected originating from theuser's right side. Other variations and queues may be utilized as theseexamples are intended to be illustrative of potential variations.

In variations where the one or more microphones are positioned inintra-buccal locations, the microphone may be integrated directly intothe electronics and/or transducer assembly, as described above. However,in additional variation, the microphone unit may be positioned at adistance from the transducer assemblies to minimize feedback. In oneexample, similar to a variation shown above, microphone unit 282 may beseparated from electronics and/or transducer assembly 280, as shown inFIGS. 27A and 27B. In such a variation, the microphone unit 282positioned upon or adjacent to the gingival surface 268 may beelectrically connected via wire(s) 264.

Although the variation illustrates the microphone unit 282 placedadjacent to the gingival tissue 268, unit 282 may be positioned uponanother tooth or another location within the mouth. For instance, FIG.28 illustrates another variation 290 which utilizes an arch 19connecting one or more tooth retaining portions 21, 23, as describedabove. However, in this variation, the microphone unit 294 may beintegrated within or upon the arch 19 separated from the transducerassembly 292. One or more wires 296 routed through arch 19 mayelectrically connect the microphone unit 294 to the assembly 292.Alternatively, rather than utilizing a wire 296, microphone unit 294 andassembly 292 may be wirelessly coupled to one another, as describedabove.

In yet another variation for separating the microphone from thetransducer assembly, FIG. 29 illustrates another variation where atleast one microphone 302 (or optionally any number of additionalmicrophones 304, 306) may be positioned within the mouth of the userwhile physically separated from the electronics and/or transducerassembly 300. In this manner, the one or optionally more microphones302, 304, 306 may be wirelessly coupled to the electronics and/ortransducer assembly 300 in a manner which attenuates or eliminatesfeedback, if present, from the transducer.

The applications of the devices and methods discussed above are notlimited to the treatment of hearing loss but may include any number offurther treatment applications. Moreover, such devices and methods maybe applied to other treatment sites within the body. Modification of theabove-described assemblies and methods for carrying out the invention,combinations between different variations as practicable, and variationsof aspects of the invention that are obvious to those of skill in theart are intended to be within the scope of the claims.

1. An apparatus for transmitting vibrations via at least one tooth tofacilitate sound transmission, comprising: a housing that is configuredto engage the at least one tooth; and an actuatable transducer disposedwithin or upon the housing and configured to transmit vibrations to asurface of the at least one tooth, wherein said apparatus produces aninterference fit between the apparatus and at least two surfaces of theat least one tooth.
 2. The apparatus of claim 1 wherein the housingcomprises an oral appliance that conforms to the at least one tooth. 3.The apparatus of claim 2 wherein the oral appliance is fabricated via athree-dimensional printing process.
 4. The apparatus of claim 2 whereinthe oral appliance is fabricated via a machining process.
 5. Theapparatus of claim 1 further comprising an electronic assembly disposedwithin or upon the housing and which is in communication with thetransducer.
 6. The apparatus of claim 5 wherein the electronic assemblyis encapsulated within the housing.
 7. The apparatus of claim 5 whereinthe electronic assembly further comprises a power supply in electricalcommunication with the transducer.
 8. The apparatus of claim 7 whereinthe power supply comprises a battery.
 9. The apparatus of claim 7wherein the power supply is rechargeable.
 10. The apparatus of claim 9wherein the power supply is rechargeable by inductance.
 11. Theapparatus of claim 5 wherein the electronic assembly further comprises aprocessor in electrical communication with the transducer.
 12. Theapparatus of claim 11 wherein the electronic assembly further comprisesa microphone for receiving auditory signals and which is in electricalcommunication with the processor.
 13. The apparatus of claim 5 whereinthe electronic assembly further comprises a receiver in wirelesscommunication with an externally located transmitter assembly.
 14. Theapparatus of claim 1 wherein the transducer is in vibratorycommunication with the housing via an adhesive for maintaining thetransducer in contact with the surface.
 15. The apparatus of claim 1further comprising an expandable osmotic pouch positioned adjacent tothe transducer such that expansion of the osmotic pouch urges thetransducer against the surface.
 16. The apparatus of claim 15 whereinthe osmotic pouch is comprised of a swellable hydrogel.
 17. Theapparatus of claim 1 wherein the transducer defines an angled surface inapposition to the surface.
 18. The apparatus of claim 1 furthercomprising an interface layer between the transducer and the surfacethrough which the vibrations are maintained.
 19. The apparatus of claim18 wherein the interface layer comprises a plastic or paste material.20. The apparatus of claim 1 further comprising an elongate support forurging the transducer against the surface upon actuation via an engagerdisposed externally of the housing.
 21. The apparatus of claim 1 furthercomprising an actuatable cam member configured to urge the transduceragainst the surface when urged via a mechanism disposed externally ofthe housing.
 22. The apparatus of claim 1 wherein the transducer ispositioned along a portion of the housing which contacts an occlusalsurface of the at least one tooth.
 23. The apparatus of claim 1 furthercomprising an engaging member having an angled interface adapted to urgethe transducer against the surface when the engaging member is forcedlinearly by pressure exerted against an occlusal surface of the at leastone tooth.
 24. The apparatus of claim 1 further comprising an anchoradhered to the surface, wherein the anchor has a configuration shaped toreceive a corresponding portion defined at least by the transducer. 25.The apparatus of claim 1 wherein the transducer is positioned within thehousing along a channel adjacent to an occlusal surface of the at leastone tooth.
 26. The apparatus of claim 1 wherein the housing is comprisedof a shape memory material having a pre-formed unbiased configurationand a deformed configuration whereby the housing is secured onto the atleast one tooth in the deformed configuration.
 27. The apparatus ofclaim 1 wherein the housing is conformable to a side surface of the atleast one tooth such that an occlusal surface of the at least one toothremains open.
 28. The apparatus of claim 1 further comprising at leastone additional actuatable transducer in vibratory communication with thesurface of the at least one tooth or a surface of at least oneadditional tooth.
 29. The apparatus of claim 28 wherein the at least oneadditional actuatable transducer is disposed within or upon the housing.30. The apparatus of claim 28 wherein the at least one additionalactuatable transducer is disposed within or upon at least one additionalhousing which is configured to engage the at least one tooth or the atleast one additional tooth.
 31. The apparatus of claim 28 wherein thetransducer and the at least one additional transducer are eachconfigured to have a frequency response and/or transmission differentfrom one another.
 32. The apparatus of claim 28 wherein each transduceris adapted to provide a sound or vibrational queue indicative of adirection in which sound is detected relative to an orientation of auser.
 33. The apparatus of claim 1 wherein the housing is configured asa mouthguard or retainer.
 34. The apparatus of claim 1 wherein thehousing is adapted to conform to at least a portion of the at least onetooth via the interference fit.
 35. The apparatus of claim 1 furthercomprising: a conduction transmission member coupled to the transducer;and a post or screw attached to a maxillary or mandibular bone and tothe conduction transmission member.
 36. The apparatus of claim 1 whereinthe housing is configured to substantially cover two or more sides ofthe at least one tooth.
 37. The apparatus of claim 1 wherein theapparatus comprises biased members to press against a surface of the atleast one tooth and secure the apparatus to the at least one tooth. 38.The apparatus of claim 1 wherein the apparatus fits over at least aportion of gingival tissue.
 39. The apparatus of claim 1 wherein theapparatus is configured as an integrated assembly.
 40. The apparatus ofclaim 1 wherein the apparatus is configured to be removable in one step.41. The apparatus of claim 1 wherein the housing comprises a polymericmaterial.
 42. A method of transmitting vibrations via at least onetooth, comprising: providing an apparatus comprising a housing and anactuatable transducer disposed within or upon the housing, wherein saidapparatus produces an interference fit between the apparatus and atleast two surfaces of the at least one tooth; positioning the housingonto the at least one tooth; and maintaining contact between a surfaceof the at least one tooth and the actuatable transducer such that thetransducer transmits vibrations to the surface of the at least onetooth.
 43. The method of claim 42 further comprising receiving anauditory signal via a microphone and actuating the transducer in acorresponding manner against the surface.
 44. The method of claim 42wherein positioning the housing comprises securing the housing againstor upon the at least one tooth.
 45. The method of claim 42 whereinmaintaining contact comprises securing the transducer via an adhesivelayer against the surface.
 46. The method of claim 42 whereinmaintaining contact comprises urging the transducer against the surfacevia an expandable osmotic pouch positioned adjacent to the transducer.47. The method of claim 42 wherein maintaining contact comprises urgingthe transducer against the surface via at least one biasing elementpositioned adjacent to the transducer.
 48. The method of claim 42wherein maintaining contact comprises positioning an interface layerbetween the transducer and the surface through which vibratorycommunication is maintained.
 49. The method of claim 42 whereinmaintaining contact comprises urging the transducer against the surfacevia an engager disposed externally of the housing.
 50. The method ofclaim 42 wherein the transducer is in contact with an occlusal surfaceof the at least one tooth.
 51. The method of claim 42 whereinmaintaining contact comprises adhering an anchor to the surface andfixedly attaching the transducer thereto.
 52. The method of claim 42wherein positioning comprises securing the housing to a side surface ofthe at least one tooth such that an occlusal surface of the at least onetooth remains open.
 53. The method of claim 42 wherein the housing isconfigured to substantially cover two or more sides of the at least onetooth.
 54. The method of claim 42 wherein the apparatus comprises biasedmembers to press against a surface of the at least one tooth and securethe apparatus to the at least one tooth.
 55. The method of claim 42wherein the apparatus fits over at least a portion of gingival tissue.56. The method of claim 42 wherein the apparatus is configured as anintegrated assembly.
 57. The method of claim 42 wherein the apparatus isconfigured to be removable in one step.
 58. The method of claim 42wherein the housing comprises a polymeric material.
 59. An apparatus fortransmitting vibrations, comprising: a housing that is configured toengage at least one tooth; and an actuatable piezoelectric transducerdisposed within or upon the housing and configured to transmitvibrations to a surface of the at least one tooth, wherein saidapparatus produces an interference fit between the apparatus and atleast two surfaces of the at least one tooth.
 60. The apparatus of claim59 wherein the housing comprises an oral appliance having a shape whichconforms to the at least one tooth.
 61. The apparatus of claim 59further comprising an electronic assembly disposed within or upon thehousing and which is in communication with the transducer.
 62. Theapparatus of claim 61 wherein the electronic assembly is encapsulatedwithin the housing.
 63. The apparatus of claim 61 wherein the electronicassembly further comprises a power supply in electrical communicationwith the transducer.
 64. The apparatus of claim 63 wherein the powersupply comprises a battery.
 65. The apparatus of claim 63 wherein thepower supply is rechargeable.
 66. The apparatus of claim 65 wherein thepower supply is rechargeable by inductance.
 67. The apparatus of claim61 wherein the electronic assembly further comprises a processor inelectrical communication with the transducer.
 68. The apparatus of claim67 wherein the electronic assembly further comprises a microphone forreceiving auditory signals and which is in electrical communication withthe processor.
 69. The apparatus of claim 61 wherein the electronicassembly further comprises a receiver in wireless communication with anexternally located transmitter assembly.
 70. The apparatus of claim 59further comprising an interface layer between the transducer and thesurface through which vibratory communication is maintained.
 71. Theapparatus of claim 59 wherein the housing is biased to urge thetransducer against the surface.
 72. The apparatus of claim 59 whereinthe housing is conformable to a side surface of the at least one toothsuch that an occlusal surface of the at least one tooth remains open.73. The apparatus of claim 59 wherein the housing is configured tosubstantially cover two or more sides of the at least one tooth.
 74. Theapparatus of claim 59 wherein the apparatus comprises biased members topress against a surface of the at least one tooth and secure theapparatus to the at least one tooth.
 75. The apparatus of claim 59wherein the apparatus fits over at least a portion of gingival tissue.76. The apparatus of claim 59 wherein the apparatus is configured as anintegrated assembly.
 77. The apparatus of claim 59 wherein the apparatusis configured to be removable in one step.
 78. The apparatus of claim 59wherein the housing comprises a polymeric material.